Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic ArthritisPulmonary SarcoidosisCrohn DiseaseUlcerative Colitis
Interventions
BIOLOGICAL

Faecal microbiota transplantation

The capsule FMT transplant consists of faeces obtained from a thoroughly screened, unpaid, anonymous stool donor. Each FMT product is made from 50g faeces diluted in sterile saline (0.9% NaCl) and glycerol, blended, centrifuged and filtered to remove particulate material before transfer to double-layered capsules. The FMT capsules will be stored at - 80 ⁰C until use. On the day of the FMT, the FMT capsules will be thawed to room temperature before treatment.

OTHER

Placebo

Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.

Trial Locations (1)

Unknown

RECRUITING

Odense University Hospital, Odense

All Listed Sponsors
collaborator

Region of Southern Denmark

OTHER

collaborator

University of Southern Denmark

OTHER

lead

Odense University Hospital

OTHER